Cleveland, OHNCT05627440Now EnrollingIRB Ready

Heart Failure Clinical Trial in Cleveland, OH

Access cutting-edge heart failure treatment through this clinical trial at a research site in Cleveland. Study-provided care at no cost to qualified participants.

Sponsored by Tufts Medical Center

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Expert Care in Cleveland

Access heart failure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure treatment provided free

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Check if you qualify for this heart failure clinical trial in Cleveland, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cleveland

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cleveland site if eligible
  4. 4Begin participation

About This Heart Failure Study in Cleveland

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.

Sponsor: Tufts Medical Center

Who Can Participate

Inclusion Criteria

Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or N-terminal pro B-natriuretic peptide (NT-proBNP) \>300 pg/mL
Age 18 years to 100 years, inclusive
Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
Any of the following markers of severe HF within prior 12 months: i) Inotropic therapy; ii) 1 or more HF hospitalizations; iii) LVEF ≤25%; iv) Peak oxygen consumption (VO2) \<50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance \<300 meters; vi) Unintentional weight loss \>5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900 pg/mL

Exclusion Criteria

Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2
An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke)
Milk allergy, protein allergy, lactose intolerance, and galactosemia
Weight ≥350 pounds and/or BMI ≥40 kg/m2
Initiation of obesity-dosed GLP-1 or GIP/GLP-1 agonist within 3 months prior to screening, or clinical intention to begin such an anti-obesity medication within the next 6 months.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT05627440) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure Treatment Options in Cleveland, OH

If you're searching for heart failure treatment options in Cleveland, OH, this clinical trial (NCT05627440) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure clinical trials near you to find additional studies recruiting in your area.

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